Recruiting
Phase 4

Testosterone Replacement

Sponsor:

University of Miami

Code:

NCT07278362

Conditions

Prostate Cancer

Hypogonadism, Male

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Testosterone cypionate

Study Details

Brief summary:

The purpose of this study is evaluate the safety of testosterone replacement therapy in men with newly diagnosed low-risk prostate cancer and hypogonadism on active surveillance.

Conditions

Prostate Cancer

Hypogonadism, Male

Study ID

NCT07278362

Start date

Nov 30, 2026

Status verified date

Oct, 2026

Completion date

May 31, 2032

Anticipated

Primary completion date

May 31, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Males aged ≥ 18 years old
  • Newly diagnosed with low-risk prostate cancer initially confirmed by fusion guided prostate biopsy (transrectal or trans perineal) by multiparametric MRI
  • Males diagnosed with low-risk prostate cancer on active surveillance
  • Two confirmatory testosterone levels <350 ng/dL (taken before 10am), with at least 24 hours and no more than 90 days between the two tests
  • Symptoms of low testosterone (Aging Male's Symptoms Score >27)
  • Able to obtain Testosterone medication through insurance or out-of-pocket
  • Willing and able to provide written informed consent and able to comply with study requirements

Exclusion Criteria:

  • Males <18 years old
  • History of Testosterone Replacement Therapy (TRT) within the past year.
  • Current use of TRT
  • Diagnosis of Gleason score 7 (Grade Group 2) prostate cancer or higher on diagnostic or confirmatory biopsy
  • PSA >10 ng/mL at baseline
  • Hematocrit > 51% at baseline
  • T3 or T4 disease
  • Unstable angina
  • History of breast cancer
  • Any other condition or situation which, in the opinion of the investigator, could impact patient safety, prevent successful data collection, or reduce the likelihood of successful study participation
  • Unable or unwilling to obtain Testosterone medication through insurance or out-of-pocket
  • Unable or unwilling to provide informed consent or comply with study requirements

Study Design

Enrollment

35 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Testosterone cypionate

Participants will self-inject 100mg of testosterone cypionate once per week for 12 months

Interventions

Testosterone cypionate

Participants will self-inject 100mg of testosterone cypionate once per week for 12 months

Primary outcome measure

  • Proportion of Participants with Disease Progression Within 12 Months After Initiating TRT [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Bruce Kava, MD

305-243-6590bkava@med.miami.edu

Laura Angulo Llanos

305-243-4850lxa2084@med.miami.edu

Locations

Desai Sethi Urology Institute

Recruiting

Miami, Florida, United States, 33136

Principal Investigator:

Thomas Masterson

Sylvester Comprehensive Cancer Center

Recruiting

Miami, Florida, United States, 33136

Principal Investigator:

Bruce Kava

More Information

Sponsor

University of Miami

Last update posted

Nov 2, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-03. This information was provided to ClinicalTrials.gov by University of Miami on 2026-11-02. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.